May 2025 FDA Recall Celecoxib by Alembic Pharmaceuticals Limited
D-0459-2025 - Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
This Class II drug recall was voluntarily initiated by Alembic Pharmaceuticals Limited on May 9, 2025 for the product Celecoxib. The FDA reported the reason for recall as presence of foreign tablets/capsules; customer complaint found one tadalafil 5mg tablet inside a sealed 500-count bottle of celecoxib 200mg capsule. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0459-2025
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
05-09-2025
06-18-2025
2,946 500-count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Alembic Pharmaceuticals Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide and in PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71
Batch or Lot Expiration Information
Batch# Batch 2405014780, Exp. Date: Sep. 30, 2027
